Bone Loss, Age-Related, Clinical Trial
Official title:
Effect of the High Impact Exercise on Bone Density in Prepuberal Girls in 12 Private Schools in Bogota - Colombia During 2016 - 2017. Open Label Randomized Controlled Trial
Osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is
a major contributing factor associated with insufficiency fracture of the spine, wrist and
proximal femur, and as a result, can diminish quality of life as well as increase direct and
indirect healthcare costs.
The pathophysiology of osteoporosis is based on two main factors; low bone mass and age
associated architectural changes within the bone, high impact exercise in childhood can
improve the peak bone mass and bone architecture. The evidence suggests that bone adaptation
to increased load is optimal in early puberty (Tanner stages I and II) since around 30% of
total body adult bone mass is accrued during this period.
However, the optimal exercise program for increasing peak bone mineral content is still
unclear. Therefore, the aim of this study is to assess if 15 minutes of high-impact exercise
three times per week improve areal bone mineral density assessed by DXA of pre pubertal
girls after a ten-month regimen compared to low-impact exercise. This information could
highly impact the development of public health policies directed to pre pubertal girls.
| Status | Suspended |
| Enrollment | 276 |
| Est. completion date | May 2017 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 8 Years to 10 Years |
| Eligibility |
Inclusion Criteria: - Girls between ages 8 to 10 - Tanner I Exclusion Criteria: - Precocious menarche (within the selected timeframe) - Chronic disorders or medications known to affect bone metabolism or musculoskeletal function. - Body Mass Index 30 or higher - Regular vigorous physical activity (training more than 8 hours per week) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Santa Fe de Bogota | Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | bone mineral density (BMD) are presented for the total Body total bone mineral density | whole body whole Amount of mineral matter per square centimeter of bones. | 36 weeks | No |